Zilurgisertib
Fibrodysplasia ossificans progressiva · Patients 12 years of age and older with fibrodysplasia ossificans progressiva
MIRM · Mirum Pharmaceuticals
Regulatory designations
Full timeline
4 milestonesFDA decision expected
FDA assigned a September 26, 2026 PDUFA target action date to the zilurgisertib NDA.
Mirum — NDA acceptance, Priority Review and PDUFA date↗Pivotal PROGRESS results were presented
The pivotal Phase 2 study reported reductions in heterotopic-ossification lesion measures and flare activity in adolescents and adults with FOP, with no adverse events leading to discontinuation or dose reduction.
Mirum and Incyte — Positive pivotal PROGRESS results↗Mirum disclosed the accepted NDA and licensed the program
Mirum obtained exclusive worldwide rights to zilurgisertib from Incyte and confirmed that FDA had accepted the NDA with Priority Review for patients age 12 and older.
Mirum — Zilurgisertib license and regulatory update↗Phase 2 PROGRESS study started
PROGRESS began evaluating zilurgisertib in adults with fibrodysplasia ossificans progressiva and later supplied the pivotal efficacy and safety dataset for the NDA.
ClinicalTrials.gov — PROGRESS study record (NCT05090891)↗Related News
No related news available.